Preventable Drug-related Morbidity (PDRM)

primarily on the basis of per-member-per-month and per-employee-per-month measures. Similarly, Nair et al. employed measures of the median, rather than the mean, and per-patient rather than per-member, in their investigation of the effects of benefit design on prescription utilization and costs. Use of these alternate measures was made necessary by the nature of their study design, which used inclusion criteria that made their subjects “patients,” chronic users of prescription drugs. Readers of the article by Nair et al. should also note that the 3 study groups were dissimilar. The authors readily acknowledge this dissimilarity in the study groups. In fact, their Table 1 shows that the only factor that was not dissimilar among the study groups was the proportion of males versus females in each. Medicare+Choice members accounted for 57.2% of the 2-tier copayment plan members who stayed in 2-tier drug plans versus zero members in each of the other 2 study groups. Others have not been as careful or thorough in measuring characteristics of study groups in a longitudinal, preintervention and postintervention design with comparison groups. Nevertheless, the findings of the work by Nair et al. in this issue of the Journal are suggestive and not definitive.

primarily on the basis of per-member-per-month and per-employee-per-month measures. Similarly, Nair et al. employed measures of the median, rather than the mean, and per-patient rather than per-member, in their investigation of the effects of benefit design on prescription utilization and costs. Use of these alternate measures was made necessary by the nature of their study design, which used inclusion criteria that made their subjects "patients," chronic users of prescription drugs.
Readers of the article by Nair et al. should also note that the 3 study groups were dissimilar. The authors readily acknowledge this dissimilarity in the study groups. In fact, their Table 1 shows that the only factor that was not dissimilar among the study groups was the proportion of males versus females in each. Medicare+Choice members accounted for 57.2% of the 2-tier copayment plan members who stayed in 2-tier drug plans versus zero members in each of the other 2 study groups. Others have not been as careful or thorough in measuring characteristics of study groups in a longitudinal, preintervention and postintervention design with comparison groups. Nevertheless, the findings of the work by Nair et al. in this issue of the Journal are suggestive and not definitive.

■■ Preventable Drug-related Morbidity (PDRM)
MacKinnon and Hepler in this issue of the Journal examine the incidence of potential examples of preventable drug-related morbidity (PDRM) in a senior, Medicare-risk population of a hospitalbased health system in Florida. 6 This study does not tie these identifiable examples of PDRM to actual clinical outcomes. Yet, the work is of interest to those dedicated to continuous quality improvement (CQI) in health care, the reduction of threats to patient safety, and maximization of opportunities to increase the frequency of favorable clinical outcomes. The method used to develop these PDRM indicators was described in a previous article in the Journal. 7 Expert panel consensus was reported for several clinical indicators of PDRM that included indicator no. 6, an emergency room (ER) visit or hospitalization due to hyperkalemia subsequent to the use of an ACE (angiotensin converting enzyme) inhibitor, without checking electrolytes and CBC at least every 6 months. By this measure, most of our elderly population on an ACE inhibitor could be at risk of PDRM. 8 The distinction between drug-related morbidity (DRM) and preventable DRM (PDRM) is of obvious importance to managed care pharmacists since PDRM would, by definition, be reducible.
More than 50% of the patients with identifiable PDRM risk factors in the study by MacKinnon and Hepler were in 3 categories (pertaining to postmyocardial infarction (MI) treatment and diabetes management) that have been addressed specifically by managed care organizations in clinical practice improvement interventions and CQI programs. In fact, significant strides have been made in the past few years to improve the quality of care for patients after MI and in the periodic and scheduled measurement of hemoglobin A1c in diabetic patients. The National Committee for Quality Assurance (NCQA) 2002 report of health care quality measures from 2001 for 271 MCOs representing 71 million members, or about 28% of the U.S. population, found improvement in several key measures. Beta-blocker use increased in 2001 to 93.5% of eligible post-MI patients compared to 89.4% in 2000, 85.0% in 1999, and 62.5% in 1996. 9 Hemoglobin A1c testing increased to 81.4% of diabetic enrollees in 2001 compared to 78.4% in 2000 and 75.0% in 1999, and hemoglobin A1c testing among Medicare enrollees was 85.3% in 2000 for NCQA-accredited MCOs versus 78.9% among nonaccredited MCOs. While managed health care systems have made significant and measurable strides in quality improvement in care processes that pertain to at least 3 of the top 5 potential PDRMs suggested by MacKinnon and Hepler, this is a moving target. While there is still opportunity to improve quality, significant improvement has been made. Examination of data from 149,177 Medicare hospital admissions for MI in 1994 and 1995 showed that the top-ranked cardiology hospitals in U.S. News & World Report' s "America' s Best Hospitals" had lower adjusted 30-day mortality (odds ratio 0.87) compared to other hospitals. Aspirin and beta-blocker use was higher in the topranked hospitals compared to other hospitals, 96% versus 89%, and 75% versus 62%, respectively. 10

■■ ERT, HRT, Raloxifine, Calcitonin, or Bisphosphonates for Osteoporosis
The sudden termination of the Women' s Health Initiative (WHI) trial of combination conjugated equine estrogen (CEE) and medroxyprogesterone acetate MPA) on May 31, 2002, precipitated a significant media event in the succeeding months. For most physicians, the "news" that estrogen and progestin in combination (hormone replacement therapy-HRT) were associated with a small increase in risk of breast cancer was not surprising, nor was it surprising that fractures were significantly lower among users of combination estrogen and progestin. Any prior use of HRT was found to be associated with a 114 cases of breast cancer over the average 5.2 years of follow-up, a rate of 1.34%, compared to 102 cases (rate of 1.26%) for women who had never taken HRT. 11 This finding combined with the results from the Heart and Estrogen/progestin Replacement Study (HERS) and HERS II suggest that combination estrogen and progestin is associated with (a) a higher risk of breast cancer than estrogen alone, 12 and (b) no protection from the risk of coronary heart disease (CHD) in either primary or secondary prevention. 13,14 WHI found increases in CHD (22%), MI (29%), stroke (41%), and pulmonary embolism (twice the rate in the placebo group). On the positive side, combination HRT was shown to result in 37% fewer cases of colon cancer, 33% fewer hip fractures, and 24% fewer fractures overall.
Physicians in the United Kingdom reacted to the news of termination of the WHI trial by requesting the continuation of clinical HRT trials. 15 British scientists recommended in mid-July 2002 that a major trial of HRT set to involve 22,000 women should continue. The U.K. study, the Women' s International Study of Long-Duration Oestrogen after Menopause (WISDOM), began in 1999 and will be conducted until the end of 2012 to determine if HRT,